Aggressive Non-Hodgkin's Lymphoma in the Elderly.
Conditions
Brief summary
To evaluate the safety and efficacy of R-COMP in elderly patients with advanced aggressive NHL. Myocet (non-pegylated liposomal doxorubicin) replaces conventional doxorubicin in the R-CHOP regimen.
Detailed description
To evaluate the duration of remission, disease free survival and 2-year survival of R-COMP in first line therapy of elderly patients with advanced aggressive NHL. To evaluate the tolerability of R-COMP in first line therapy of elderly patients with advanced aggressive NHL.
Interventions
DRUGCyclophosphamide, oncovin, myocet, prednisone & rituximab (R-COMP)
Sponsors
Zeneus Pharma
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diffuse Large B-Cell Lymphoma (DLBCL), and their morphologic variants and subtypes, i.e. Centroblastic lymphoma, Immunoblastic lymphoma, T-cell rich/B-cell lymphoma, anaplastic large B-cell lymphoma, mediastinal (thymic) large B-cell lymphoma; * Primary diffuse large B-cell lymphoma of MALT (incorrectly defined as high-grade MALT lymphoma); * Marginal zone B-cell lymphoma with coexisting areas of DLBCL; * Age of ≥60 years; * Clinical stage at diagnosis: I A bulky - IV B; * CD20 positivity; * Serum negativity for HbsAg and HCV except for those with no sign of active viral replication, assessed by HCV-RNA copies; * Absolute neutrophil count (ANC) ≥1.5x109/L, and platelet count ≥100x109/L (unless both are attributed directly to bone marrow involvement by lymphoma or auto-immune disease secondary to lymphoma); * Serum creatinine ≤130μM/L, serum bilirubin ≤2.5xULN aspartate amino-transferase (AST/GOT), ≤2.5xULN alanine amino-transferase (ALT/GPT) ≤2.5xULN, and alkaline phosphatase ≤4 times the upper limit of normal (unless the increase is attributed directly to the presence of tumour by the Investigator) * Left ventricular ejection fraction (LVEF) ≥50%; * ECOG performance status 0-2; * At least one measurable lesion is mandatory; * Written informed consent given at time of registration; * Males and females (both males and females of childbearing potential must agree to use adequate contraception for the duration, and for 3 months after the completion, of the treatment).
Exclusion criteria
* Clinical stage I non-bulky, or CS IIA with less than three sites of disease involved (patients with stage IIB are eligible, regardless of the number of sites involved); * Tumour involvement of CNS; * Indolent lymphoma transformed in more aggressive histological type, even if never previously treated; * Mantle Cell Lymphoma, Peripheral T cell Lymphoma and their variants; * Aggressive non-Hodgkin's lymphoma in transplanted patient; * Clinically significant secondary cardiovascular disease, e.g. uncontrolled hypertension, (resting diastolic blood pressure \>115 mmHg), uncontrolled multifocal cardiac arrhythmias, symptomatic angina pectoris or congestive cardiac failure NYHA class III-IV; * Evidence of any severe active acute or chronic infection; * Concurrent malignancy or history of other malignancy, except basal cell carcinoma of the skin (BCC) and in-situ cervical carcinoma (CIN) / Myelodysplastic syndrome; * HbsAg, HIV-positive, or HCV-RNA-positive patients; * Inability to comply with study procedures; * Prior CNS lymphoma; * Prior radiation to non-CNS lymphoma mass(es) as a treatment for lymphomas; * History of allergic reaction to anthracyclines, eggs, and egg products or known sensitivities, or history of unusual reaction, to other components of, or treatments similar to, the investigational treatment regimen; * Presence of other medication that may interfere with study treatment or the action of the investigational product or confuse the assessment of study results * Pregnant women or nursing mothers; * Participation in an investigational drug study within 4 weeks prior to study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Countries
France, Germany, Italy, Spain, United Kingdom
Outcome results
None listed